An Observational Real World Study on the Efficacy and Safety of Toripalimab Injection Combined With TACE in the Treatment of Extrahepatic Cholangiocarcinoma
NCT05448183 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2022-07-07
Summary
This is an open-label, single-arm, multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with TACE in the treatment of extrahepatic cholangiocarcinoma.
Conditions
- Extrahepatic Cholangiocarcinoma
Interventions
- DRUG
-
Toripalimab, Gemcitabine,Oxaliplatin
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), combined withTACE (Gemcitabine 1000mg/m2 , Oxaliplatin 135mg/m2) in a cycle of 3 weeks(q3w).
Sponsors & Collaborators
-
Xuhua Duan
lead OTHER
Principal Investigators
-
Hua xu Duan, Doctor · The First Affiliated Hospital of Zhengzhou University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-15
- Primary Completion
- 2023-05-15
- Completion
- 2024-05-15
Countries
- China
Study Locations
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